Application 077066

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	75MG;25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL	AB		2005-04-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077066-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077066-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077066-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077066-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077066-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077066-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077066-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077066-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077066-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077066-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077066-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077066-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077066-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077066-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077066-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077066-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077066-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077066-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077066-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077066-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077066-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077066-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077066-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077066-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077066-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077066-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077066-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077066-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077066-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077066-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077066-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077066-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077066-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077066-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077066-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077066-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077066-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077066-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077066-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077066-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077066-001	AB	1	`e64feba35796…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	REMEDYREPACK INC.	ae892973-9ef4-4cf0-baf3-fbe158697bac	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066 ndc (product): 70518-1087
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	St. Mary's Medical Park Pharmacy	87210c87-b7db-0f65-e053-2a91aa0a4393	2026-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066 ndc (product): 60760-194
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	0631d961-ef23-8f2a-e063-6294a90aa0a8	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	PD-Rx Pharmaceuticals, Inc.	7767697f-4dd0-477d-b5cc-e1ed5689f097	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066 ndc (product): 72789-234
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	PD-Rx Pharmaceuticals, Inc.	643cdcff-8599-4326-b3ca-d9fd270e0fc2	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066 ndc (product): 72789-242
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	04b4189e-9b21-78ed-e063-6394a90ab8e0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	QPharma, Inc.	fbc05ccb-782b-55f6-e053-6394a90a7fd6	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	A-S Medication Solutions	b644426c-c8ba-4fe0-80c7-d9b2dde37395	2025-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
NITROFURANTOIN	NITROFURANTOIN	Directrx	d4385368-46d6-8397-e053-2a95a90a8d68	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066 ndc (product): 72189-179
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	68a651f9-1aef-792e-e053-2991aa0a3cbb	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066 ndc (product): 68071-4367
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	6bccbaab-151b-4a04-e053-2991aa0ae105	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066 ndc (product): 68071-4428
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Sandoz Inc	7ba9a729-a73a-4a13-a336-0284cc8a67e1	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066 ndc (product): 0185-0122
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Bryant Ranch Prepack	05f4b126-0fb9-5ee9-c89c-f229e60f84e3	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066 ndc (product): 63629-1748
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Asclemed USA, Inc.	1ab658f0-021a-46a1-bff3-d3334c23442d	2022-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066 ndc (product): 76420-195
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Proficient Rx LP	d802d734-dc8f-4f3c-bce6-aaccc4614c89	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066 ndc (product): 63187-995

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 66 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0122	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Eon Labs, Inc.	ANDA	Current
0185-0122	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Eon Labs, Inc.	ANDA	Current
0185-0122	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Eon Labs, Inc.	ANDA	Current
0185-0122	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Eon Labs, Inc.	ANDA	Current
0185-0122	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Eon Labs, Inc.	ANDA	Current
0480-3470	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Teva Pharmaceuticals USA, Inc.	ANDA	Current
16714-439	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Northstar RxLLC	ANDA	Current
16714-439	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Northstar RxLLC	ANDA	Current
16714-439	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Northstar RxLLC	ANDA	Current
50090-3737	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)	A-S Medication Solutions	ANDA	Current
50090-3737	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)	A-S Medication Solutions	ANDA	Current
50090-3856	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)	A-S Medication Solutions	ANDA	Current
53002-7041	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-7041	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-822	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Quality Care Products, LLC	ANDA	Current
55700-822	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Quality Care Products, LLC	ANDA	Current
55700-822	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Quality Care Products, LLC	ANDA	Current
60760-194	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	St. Mary's Medical Park Pharmacy	ANDA	Current
63187-995	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Proficient Rx LP	ANDA	Current
63187-995	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Proficient Rx LP	ANDA	Current
63187-995	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Proficient Rx LP	ANDA	Current
63629-1459	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-1459	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-1459	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-1748	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-1748	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-1748	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-1748	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-7968	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
68071-4367	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4367	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4367	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4428	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4428	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4428	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5076	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5076	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-446	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	American Health Packaging	ANDA	Current
68084-446	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	American Health Packaging	ANDA	Current
68084-446	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	American Health Packaging	ANDA	Current
68084-446	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	American Health Packaging	ANDA	Current
68084-446	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	American Health Packaging	ANDA	Current
68788-7092	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7092	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7092	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7092	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7092	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1087	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	REMEDYREPACK INC.	ANDA	Current
70518-1087	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	REMEDYREPACK INC.	ANDA	Current
70518-1087	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	REMEDYREPACK INC.	ANDA	Current
70518-1087	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	REMEDYREPACK INC.	ANDA	Current
70518-1087	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	REMEDYREPACK INC.	ANDA	Current
70518-1087	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	REMEDYREPACK INC.	ANDA	Current
70934-269	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-269	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-269	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-546	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Proficient Rx LP	ANDA	Current
71205-546	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Proficient Rx LP	ANDA	Current
72189-179	NITROFURANTOIN	NITROFURANTOIN	Directrx	ANDA	Current
72189-179	NITROFURANTOIN	NITROFURANTOIN	Directrx	ANDA	Current
72789-234	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-242	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-242	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-242	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
76420-195	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Asclemed USA, Inc.	ANDA	Current
76420-195	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Asclemed USA, Inc.	ANDA	Current